Public Health Groups Sue FDA Over Delay of E-cigarette Review

[PJReid]

Every news outlet has an article about today's lawsuit. On the one hand, it is frightening to see how far this is being taken by advocacy groups. On the other hand, tying the issue up in court will delay resolution indefinitely.

https://www.usnews.com/news/busines...it-challenges-fda-delay-of-e-cigarette-review

"The lawsuit filed Tuesday in federal court argues that the FDA didn't follow proper requirements last year when it decided to push back the deadline for makers of e-cigarettes to submit their products for review. The groups say the delay poses a threat to children's health."

 

[Rossum]

So the contention here, is that the FDA, which extended its own authority over these products by "deeming" them to be tobacco products, does not have the authority to delay implementation of some aspects of the very regulations it promulgated?

An argument like this might make sense if there were statutory law that required the FDA to implement any of this by a certain date, but there isn't. The only applicable statute is the Marlboro Protection Act of 2009, which doesn't even mention electronic cigarettes or vaping!

 

[zoiDman]

Never stopped them before.

I mean, who Many Times has the American Academy of Pediatrics sued the FDA over e-Cigarettes?

 

[PJReid]

Not under its own authority - the authority to regulate vape gear as a tobacco product was handed to the FDA on a silver platter.

“Congress gave the FDA broad authority to deem new products to be ‘tobacco products’ subject to that existing statutory regime, and the Court finds that it was not arbitrary and capricious for the agency to decide to take that action with respect to e-cigarettes.” - Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia

"The costly reviews of these products were required under new rules finalized by the outgoing Obama administration in May 2016 that for the first time gave the FDA authority to regulate cigars and e-cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act."

 

[Rossum]

Never stopped them before.

I mean, who Many Times has the American Academy of Pediatrics sued the FDA over e-Cigarettes?

TBH, I have no idea.

 

[zoiDman]

Here are 3 actions I can think of off the Top of my head.

American Academy of Pediatrics v. U.S. Food & Drug Administration | Public Health Law Center

Leading Health Organizations Seek to Intervene in Defense of FDA Rule on E-Cigarettes, Cigars | American Heart Association

http://caselaw.findlaw.com/us-dc-circuit/1593752.html

 

[PJReid]

There are dozens of lawsuits, some decided, some not. In the one I referenced above, in DC's US District Court, is likely being appealed. This is the first lawsuit against the FDA for delaying the enforcement of the Deeming Regulations. Maybe the lawsuit is a good thing in that agency overreach, the "right" to classify electronics as "tobacco products" and so on will be hashed out in court. It will take a long time and will be appealed by the losing party, whichever side that is, in the 4th District Federal Appeals Court. Again, it will take a long, long time.

 

[Sugar_and_Spice]

I guess they must not have anything better to do. I am thinking that maybe they have shot themselves in the foot by trying to force the FDA to comply with their demands. There are new studies coming forth that are leaning in favor of ecigs being a better alternative to smoking and maybe they want a solid ban before the new data surfaces? Don't see this being heard on a quick basis, but I could be wrong.

 

[Bill Godshall]

The vapor prohibitionist's lawsuit against Gottlieb and FDA (and press releases and news clips) are at

https://www.tobaccofreekids.org/assets/content/press_office/2018/2018_03_27_filing.pdf

Academy, health groups sue FDA over e-cigarette regulation delays

Health Groups File Suit to Expedite FDA Review of E-Cigarettes, Cigars

Health Groups Sue FDA Over Delay in Deeming Regulations - halfwheel

Lawsuit challenges FDA delay of e-cigarette review

The first (and perhaps greatest) hurdle for the vapor prohibitionists is to gain Standing in the case, which is why the plaintiffs deceitfully portrayed themselves as poor innocent victims who were injured by FDA's four year delay in banning vapor sales until 8/8/2022.

When these same groups sued to intervene in defense of FDA's Deeming Rule, the judge denied them Standing in that case. Hopefully, the same will occur in this case.